Kornimate/medical-research-clean huggingface dataset:
a study comparing two treatments for infants with hydrocephalus

Conditions: Hydrocephalus

Summary: the purpose of this study is to study whether infants with triventricular hydrocephalus (tvh) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (etv), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (csf) shunt.

tvh is a relatively uncommon condition in infants, in which csf accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. this can cause increased intracranial pressure, with adverse effect on brain development. the causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection. tvh is currently treated through one of the following two approaches: * extra-cranial csf diversion through ventricular shunts. extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully. * intra-cranial internal csf diversion using endoscopic techniques. the principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. however, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. there is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (etv).

Eligibility criteria:
inclusion criteria: * symptomatic tvh requiring treatment. * no previous treatment for tvh * under 24 months of age at time of surgery * full-term pregnancy (\>36 weeks) * mandatory pre-operative mri that includes mid-sagittal t1 \& t2 scans which show: tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of csf collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete dandy walker syndrome excluded); questionable flow in aqueduct acceptable as long as tvh exists * history or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity). * ability to participate in followup for at least 5 years exclusion criteria: * open spina bifida * complete dandy walker syndrome (vermian agenesis / dysgenesis) * prematurity * perinatal asphyxia * severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts) * intracranial tumor

Keywords: infants hydrocephalus cerebrospinal fluid shunt ventriculostomy neurosurgery
a bioequivalence study of docetaxel for injectable emulsion (anx-514) in patients with advanced cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to compare an injectable emulsion form of docetaxel to taxotere in patients with advanced cancer.


Eligibility criteria:
inclusion criteria: * over 18 years old. * advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment. * ecog performance status of 0-2 and karnofsky score of 100-70. exclusion criteria: * patients who have more effective therapy available than single agent docetaxel for the malignancy. * pregnancy or lactation. * intolerance to any antineoplastic agents belonging to the taxoid family. * hypersensitivity to drugs formulated with polysorbate 80. * active infection. * prior anticancer therapy within 30 days prior to the first day of study treatment. * participation in another experimental drug study within 30 days prior to the first day of study treatment.
electronic pre-exposure prophylaxis (prep) initiation and maintenance home care system

Conditions: Pre-exposure Prophylaxis

Summary: the premise for the study is that a tailored approach for rural young men who have sex with men (ymsm), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of pre-exposure prophylaxis (prep) initiation and persistence in care.

the premise for the study is that a tailored approach for ymsm from rural and small town areas, addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of prep initiation and persistence in care. the study sites are alabama, georgia, north carolina, and mississippi. using a smartphone application (app), participants assigned to the intervention will receive and maintain a prep prescription without needing to leave their home (excepting pharmacy pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine consultations, and home specimen self-collection.

Eligibility criteria:
inclusion criteria: * assigned male at birth * age 18-29 (inclusive) * live in a study state (georgia, mississippi, north carolina, alabama) * able to provide informed consent and complete survey instruments in english * willing to provide complete contact information (including 2 alternate contacts) * able and willing to provide identification verification for viewing confirmation only * laboratory confirmed hiv negative * owns a smartphone capable of running the study app * male sex partners in past 6 months or clinician discretion of epidemiologic context of hiv risk * behavioral/epidemiological indication for prep : * history of inconsistent or no condom use with more than one partner * history of inconsistent or no condom use with one partner who is not mutually monogamous * hiv-positive sexual partner * any sexually transmitted infection (sti) diagnosed in past 6 months * commercial sex work * african american msm reporting anal sex in the past 6 months * clinician discretion based on epidemiologic context of hiv risk * willing to take fda-approved daily oral prep * willing to use study-provided prep navigation services * willing to self-collect specimens exclusion criteria: * hiv positive (self-report or laboratory confirmed) * chronic hepatitis b or no verification of hepatitis b vaccination * currently enrolled in any hiv prevention trial (biomedical) * currently taking oral prep based on self-report * creatinine clearance \<60 ml/min based on the cockcroft-gault equation * symptoms of acute hiv infection within the prior 30 days * contraindications to oral prep * personal diagnosis or family history of hemophilia * health insurance with kaiser permanente (unable to prescribe prep through the study) * investigator discretion to exclude anyone whose best interest is not to participate * evidence of fraudulent participation, such as duplicate internet protocol (ip) address, multiple screening attempts, duplicate emails, etc

Keywords: prep msm hiv telemedicine randomized controlled trial
awake thoracic epidural anaesthesia versus general anesthesia for video assisted thoracoscopic surgery

Conditions: Lung Cancer

Summary: thoracic procedures are routinely performed under general anesthesia (ga), with one lung ventilation (olv)by double lumen tube or (ga) in spontaneously breathing patient by tiva or lma are usually combined with thoracic epidural analgesia. however, ga whether mechanically ventilated or spontaneously breathing may have adverse effects including peri-intubation hypoxia, trauma to the upper airway, mechanical ventilation-induced injuries, impaired cardiac performance, neuromuscular problems in olv and increased risk of pneumonia, and release of proinflammatory mediators in generally. recently, awake thoracic epidural anesthesia (atea) has been used alone in thoracic procedures the results achieved in early studies have been encouraging. atea may eventually provide an alternative method to ga for thoracic procedures that would not only eliminate the need for ga but also facilitate both surgical reconstruction and eventually patient recovery. recent studies suggested better clinical outcomes with atea, including less intraoperative bleeding, a better control of postoperative pain, early mobilization and short hospital stay, oral intake tolerance, reduction of surgical stress response, reduction of intraoperative cardiac events, improvement of myocardial flow determinants and left ventricular function, and a reduction of complications including pulmonary, thrombotic and infectious events.


Eligibility criteria:
inclusion criteria: * age range between 18 and 60 years. * asa score equal to or less than iii. * the absence of severe emphysema or clinical signs of active infectious disease. * the procedure is predicted to be completed within two hours. exclusion criteria: * patients with expected difficult airway management * haemodynamically unstable patients * obesity (body mass index \>30) * inexperienced and poorly cooperative surgical team * coagulopathy (international normalized ratio \>1.5) * persistent cough or high airway secretion * neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain oedema * extensive pleural adhesions or previous pulmonary resections * hypoxaemia (pao2 \ 50) * any contraindications for use of regional anesthesia technique
postoperative cardiovascular index change of primary aldosteronism

Conditions: Aldosteronism

Summary: primary aldosteronism (pa), characterized by an inappropriate production of aldosterone, is far more common than is usually perceived. the overall prevalence of pa is 11.2% of the newly diagnosed hypertensive patients and 4.8% was curable aldosterone producing adenoma (apa), and adrenalectomy is considered the treatment of choice for apa. the potential curability and prevention of excess cardiovascular damage and events also underscores the need to develop accurate strategies for the timely diagnosis of apa.this study aimed to determine the effects of endothelium function change ( pwv, progenitor cell,..) before and post-adrenalectomy or taking spironolactone in patients with aldosteronism. autonomous elevated aldosterone will increase the glomerular filtration rate and renal damage in patients with primary aldosteronism (pa). but clinical evidence of the role of endothelium function on post-adrenalectomy or taking spirolactone is still limited.

aldosterone has rapid nongenomic effects in the human vasculature. aldosterone has been claimed to lead to endothelial dysfunction, a condition related to development of cardiovascular disorders and to poor prognosis. however, studies of aldosterone effects on endothelial function led to discrepant findings, which may be related, at least in part, to inhomogeneity of the populations studied. thus, studies in healthy subjects showed no detrimental effects of aldosterone on endothelial function and no positive effect of aldosterone inhibition, whereas populations with established cardiovascular diseases showed negative effects of aldosterone and positive effects of spironolactone therapy. still, other factors may be of importance as effects of aldosterone on endothelial function are not homogenous even in a healthy population. dosages of aldosterone, concomitant drug use, as well as the vascular bed investigated may influence the effects observed. furthermore, little is known about chronic endothelial effects of aldosterone that could indicate a primary and direct role of aldosterone in development of cardiovascular diseases. in patients with hyperaldosteronism diminished flow-mediated dilation was found, indicating impaired endothelial function compared with hypertensive patients without elevated aldosterone. however, it is not known whether these results represent endothelial dysfunction as the result of a direct aldosterone effect on the vasculature or a secondary effect attributable to more substantial hypertension.

Eligibility criteria:
inclusion criteria: * aldosteronism with hyperaldosterone * older than 18 year of age * completed the informed consent exclusion criteria: * pregnancy * bed-ridden * could not do mri

Keywords: cardiovascular disease, endothelium function, aldosterone
benign/malignant pulmonary nodule classification based on high-throughput whole-genome methylation sequencing(gm-seq)

Conditions: Pulmonary Nodule, Solitary; Whole-genome Methylation Sequencing

Summary: lung cancer is the first cancer in china in terms of morbidity and mortality. the problem of early diagnosis/treatment has always been concerned. the popularization of chest ct (electronic computed tomography) screening makes it possible to detect lung cancer early. however, the diagnosis still needs pathological evidence. it is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. however, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctdna (circulating tumor dna) in the current detection samples. therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "whole genome methylation sequencing(gm-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.


Eligibility criteria:
inclusion criteria: 1. male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest ct; 2. the nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection; 3. patient accept imaging evaluation without advanced lung tumors and metastases; 4. the location of the nodule in the lung is within the reach of lung biopsy under bronchoscope; 5. provide the collected clinical data needed by the research; 6. patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits. exclusion criteria: 1. unwilling to accept the invasive examination and treatment of this study; 2. contraindication of tracheoscopy; 3. consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer; 4. those who cannot tolerate resection of pulmonary nodules; 5. accompanied by other malignant tumors; 6. in the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test; 7. those who cannot accept the use of contrast-enhanced magnetic resonance imaging (mri) or contrast-enhanced computed tomography (ct); 8. any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study.

Keywords: ctdna pulmonary nodule, solitary whole-genome methylation sequencing(gm-seq) machine learning
risk factors and a prediction model of recurrence of uterine fibroids

Conditions: Uterine Fibroid; Recurrence

Summary: to research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.

uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. with the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. however, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems. according to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. at the eighth year of myomectomy, the recurrence rate is as high as 84.4%. during the long-term follow-up, about one-third of patients eventually require reoperation. recurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security.

Eligibility criteria:
inclusion criteria: 1. age:18-50 years 2. diagnosed with uterine fibroids （by ultrasound or pathology） 3. accept myomectomy. 4. complete clinical data. exclusion criteria: 1. severe infectious disease 2. previous history of malignant tumors 3. incomplete clinical data. 4. pregnant

Keywords: uterine fibroid recurrence risk factor prediction medel
effect of phenylephrine during shoulder arthroscopic surgery

Conditions: Disorder of Shoulder; Anesthesia

Summary: the purpose of this study is to determine whether phenylephrine infusion are effective in the prevention of hypotension after changing position to beach chair position during general anesthesia for shoulder arthroscopic surgery. investigators hypothesized that by increasing arterial blood pressure with phenylephrine infusion, incidence of hypotension would be decreased.

the beach chair position is associated with hypotension, risk of cerebral hypoperfusion, and cerebral injury. sixty-six patients undergoing elective shoulder arthroscopic surgery are randomized to receive either phenylephrine low dose (0.5 mcg/kg/hr), phenylephrine high dose (1.0 mcg/kg/min), or normal saline 5 minute before being placed in the beach chair position. general anesthesia is induced with propofol, remifentanil and rocuronium (0.6 mg/kg) and the trachea intubated. anesthesia is maintained with sevoflurane and remifentanil targeting for a bis value 40-60. after hemodynamic stabilization, patients received on infusion of either phenylephrine high dose (1.0 mcg/kg/min), phenylephrine low dose (0.5 mcg/kg/hr) or normal saline 5 minute before being placed in the beach chair position. following 15 minutes of infusion study drugs, measurements of mean arterial blood pressure and cardiac function (stroke volume variation, stroke volume index, and cardiac index) using vigileo/flotrac system were made.

Eligibility criteria:
inclusion criteria: * shoulder arthroscopic surgery undergone beach chair position exclusion criteria: * history of cerebrovascular event, * significant cardiac disease (new york heart association symptoms class ≥ 3) * uncontrolled hypertensive patients. * american society of anesthesiologist class 4,5

Keywords: shoulder phenylephrine hypotension
role of presepsin as a novel biomarker in diagnosis of neonatal sepsis

Conditions: Neonatal Sepsis

Summary: -introduction: sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection. it is life-threatening entity causing millions of deaths worldwide, with variable clinical manifestations and poses difficulty in diagnosis and treatment. early recognition of sepsis not only helps in the optimization of treatment but also improves the overall outcome. neonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria , viruses, fungi ,or parasites or the toxic products of these., it is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges .the proof of infection is seldom encountered in practice, as the confirmatory microbial culture yield can be as low as 25-30%. hence, clinicians often depend on commonly available biomarkers such as c-reactive protein (crp) and procalcitonin (pct) for diagnosing infection. even though helpful, these markers are fraught with errors and limitations there is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions the role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry. cd14 is a co-receptor present on the surface of the monocyte/macrophage. it is a member of the toll-like receptors (tlrs),with an ability to identify groups of ligands of both gram-positive and gram-negative pathogens cd14 exists in two forms namely membrane-bound (mcd14) and a soluble form (scd14). the scd14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin d . the n terminal fragment of the scd14-st subtype is called presepsin.


Eligibility criteria:
inclusion criteria: * neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis, e.g., ( prolonged labor, premature rupture of membrane (prom), maternal intrapartum fever and chorioamnionitis,) and neonates with sepsis-related clinical signs: (temperature instability, apnea, need for supplemental oxygen, bradycardia, tachycardia, hypotension, hypoperfusion, feeding intolerance, and abdominal distension). exclusion criteria: * administration of antibiotic therapy prior to admission, birth asphyxia laboratory finding suggestive of inborn error of metabolism congenital anomalies including congenital heart disease
mivetscan: can-coach trial (phase 1)

Conditions: Chronic Pain

Summary: the goal of the mivetscan can-coach trial is to pilot and modify a trial of four coaching sessions to help veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

all study interactions will be done virtually and recruitment data is exploratory.

Eligibility criteria:
inclusion criteria: * united states veteran * experiencing chronic pain (pain lasting 3 or more months) * worst pain of ≥3 out of 10 using a 0-10 numeric rating scale (nrs) * are planning or currently using cannabidiol (cbd) or cannabis products for pain management * able to read and speak english sufficiently to allow for informed consent and active participation in the educational intervention sessions * willingness to attend all study visits (conducted virtually) * willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details) exclusion criteria: * inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in english) * participant states participant is pregnant * current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition) * current diagnosis or past history of bipolar disorder * unable to attend study visits * risk for eminent harm - suicidal ideation or wish to die as assessed with the positive and negative suicide ideation (pansi) questionnaire and further risk assessment by study team members * any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol

Keywords: veteran cannabis